(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Multiple products were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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It was reported that on (b)(6) 2015, patient underwent revision surgery from l5-s1.The rhbmp-2 collagen sponge was placed outside a cage (i.E., between the transverse processes) due to severe pain.Patient continued to experience constant lower back pain, with pain radiating down to her left leg, numbness in her feet, and swelling in her lower back and feet.She also experienced difficulty sitting, standing and walking due to pain.
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